Critical IllnessNCT06109740
Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
A study testing lactobacillus GG in people with Critical Illness and Antibiotic-associated Diarrhea, run by University of South Alabama.
Trial summary
The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question[s] it aims to answer are: Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU Is lactobacillus safe in critically ill pediatric patients Participants will be… Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Critical Illness, Antibiotic-associated Diarrhea
- What is being tested?
- lactobacillus GG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to PICU
- Requiring > 72 hrs of antibiotic therapy
- < 17 years
- Able to administer oral LGG or placebo
Who cannot join
- Antibiotics 48 hours prior to hospital admission
- Probiotic use within 7 days of admission
- Pre-existing diarrhea at time of hospital admission or 24 hours prior to admission
- Laxative therapy at time of admission or 48 hours prior to admission
- HIV with CD4 < 250
- Established immunologic deficiencies (ANC < 100)
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- Chronic steroid therapy ( > 10 days)
- GI disorders including intussusception, lower bowel disease, bowel resection, irritable bowel syndrome, ulcerative colitis, or Crohn's disease
- Status post-surgical patients with antibiotic prophylaxis (< 72 hours duration)
- NPO
About this study
The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question[s] it aims to answer are:
- Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU
- Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics
If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.
Read the detailed description
The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the PICU.
Design:
Prospective randomized, double-blind, placebo-controlled trial
Setting:
15-20 bed PICU at University of South Alabama, Children's and Women's Hospital in Mobile, Alabama.
Patients:
Pediatric patients ≤ 17 years and required antibiotic therapy ≥ 72hrs were randomized to receive placebo or control (lactobacillus GG). Exclusion criteria included but was not limited to antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and GI disorders.
Interventions:
Treatment with LGG (30 x 109 CFU) or a matching placebo capsule was administered twice daily, initiated within 24 hours of starting antibiotic therapy and continued for the duration of therapy.
Measurements:
Diarrhea was defined as stools >200 mL or 200 g per day in a patient over 10 kg and > 20 mL/kg/day or > 20 g/kg/day in a patient < 10 kg or 3 or more loose stools in 24 hours.
- Conditions
- Critical Illness, Antibiotic-associated Diarrhea
- Being tested
- lactobacillus GG
- Keywords
- Pediatric, PICU
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactobacillus GGDietary supplement
probiotic
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus GG | Experimental | Probiotic nutritional supplement Receives: Dietary Supplement: lactobacillus GG |
| Placebo capsule | Placebo comparator | Matching placebo capsule Receives: Dietary Supplement: lactobacillus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of antibiotic associated diarrhea
Diarrhea was defined as stools >200 mL or 200 g per day in patients over 10 kg and > 20 mL/kg/day or > 20 g/kg/day in patients < 10 kg or 3 or more loose stools in 24 hours if the stools were not able to be weighed. When patients developed diarrhea lasting more than 72 hours, they were crossed over to the alternate treatment arm.
Measured: Full time while on antibiotics and 48 hours after
Secondary outcomes (1)
Tolerability of lactobacillus GG
Assessment of any adverse events related to lactobacillus GG
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startOct 2008
- Primary completionOct 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective randomized, double-blind, placebo-controlled crossover trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Collaborators
- Amerifit Brands Inc
- Responsible party
- Principal investigator, Allison Chung, University of South Alabama
- Investigators
- Allison Chung, Principal investigator, University of South Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109740
- Sponsor's protocol ID
- 08-218
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only deidentified data
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06109740
- Acronym / sponsor ID
- 08-218
- Conditions
- Critical Illness, Antibiotic-associated Diarrhea
- Keywords
- Pediatric, PICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Collaborators
- Amerifit Brands Inc
- Study start
- Oct 2008 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question[s] it aims to answer are:
- Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU
- Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics
If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.
Detailed description
The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the PICU.
Design:
Prospective randomized, double-blind, placebo-controlled trial
Setting:
15-20 bed PICU at University of South Alabama, Children's and Women's Hospital in Mobile, Alabama.
Patients:
Pediatric patients ≤ 17 years and required antibiotic therapy ≥ 72hrs were randomized to receive placebo or control (lactobacillus GG). Exclusion criteria included but was not limited to antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and GI disorders.
Interventions:
Treatment with LGG (30 x 109 CFU) or a matching placebo capsule was administered twice daily, initiated within 24 hours of starting antibiotic therapy and continued for the duration of therapy.
Measurements:
Diarrhea was defined as stools >200 mL or 200 g per day in a patient over 10 kg and > 20 mL/kg/day or > 20 g/kg/day in a patient < 10 kg or 3 or more loose stools in 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective randomized, double-blind, placebo-controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus GG | Experimental | Dietary Supplement: lactobacillus GGProbiotic nutritional supplement |
| Placebo capsule | Placebo comparator | Dietary Supplement: lactobacillus GGMatching placebo capsule |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Admitted to PICU
- Requiring > 72 hrs of antibiotic therapy
- < 17 years
- Able to administer oral LGG or placebo
Key exclusion criteria (10 listed)
- Antibiotics 48 hours prior to hospital admission
- Probiotic use within 7 days of admission
- Pre-existing diarrhea at time of hospital admission or 24 hours prior to admission
- Laxative therapy at time of admission or 48 hours prior to admission
- HIV with CD4 < 250
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lactobacillus GGprobiotic | Dietary supplement | Lactobacillus GG, Placebo capsule |
Primary outcome
Incidence of antibiotic associated diarrhea
Time frame: Full time while on antibiotics and 48 hours after
Diarrhea was defined as stools >200 mL or 200 g per day in patients over 10 kg and > 20 mL/kg/day or > 20 g/kg/day in patients < 10 kg or 3 or more loose stools in 24 hours if the stools were not able to be weighed. When patients developed diarrhea lasting more than 72 hours, they were crossed over to the alternate treatment arm.
1 secondary outcome
Tolerability of lactobacillus GG
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No. Only deidentified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Chung principal investigator
University of South Alabama
Questions about this trial
What is this clinical trial studying?
A study testing lactobacillus GG in people with Critical Illness and Antibiotic-associated Diarrhea, run by University of South Alabama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of antibiotic associated diarrhea (time frame: Full time while on antibiotics and 48 hours after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.